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510(k) K163357

OneTouch Via On-Demand Insulin Delivery System by Lifescan Europe, A Division of Cilag GmbH — Product Code OPP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2017
Date Received
November 30, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Insulin Bolus
Device Class
Class II
Regulation Number
880.5725
Review Panel
CH
Submission Type

The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus.

Other clearances for product code OPP

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  • K243273 — CeQur Simplicity™ On-Demand Insulin Delivery System (November 13, 2024)
  • K233447 — CeQur Simplicity™ On-Demand Insulin Delivery System (January 18, 2024)
  • K111924 — FINESSE PERSONAL INSULIN DELIVERY PATCH (April 10, 2012)
  • K100947 — FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000 (June 28, 2010)
  • K093065 — FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000 (January 20, 2010)